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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MIRIKIZUMAB-MRKZ: 567 Adverse Event Reports & Safety Profile

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567
Total FAERS Reports
17 (3.0%)
Deaths Reported
123
Hospitalizations
567
As Primary/Secondary Suspect
9
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761279 ·

First Report: 20090101 · Latest Report: 20250923

What Are the Most Common MIRIKIZUMAB-MRKZ Side Effects?

#1 Most Reported
Colitis ulcerative
94 reports (16.6%)
#2 Most Reported
Injection site pain
71 reports (12.5%)
#3 Most Reported
Drug ineffective
47 reports (8.3%)

All MIRIKIZUMAB-MRKZ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Colitis ulcerative 94 16.6% 2 33
Injection site pain 71 12.5% 0 3
Drug ineffective 47 8.3% 0 11
Arthralgia 22 3.9% 0 2
Rash 21 3.7% 0 3
Diarrhoea 20 3.5% 0 9
Headache 19 3.4% 0 1
Incorrect dose administered 17 3.0% 0 0
Maternal exposure during pregnancy 16 2.8% 0 1
Dizziness 15 2.7% 0 2
Haematochezia 15 2.7% 0 4
Frequent bowel movements 14 2.5% 0 8
Abdominal pain 13 2.3% 0 7
Fatigue 12 2.1% 0 1
Off label use 12 2.1% 3 5
Pyrexia 12 2.1% 0 4
Pruritus 11 1.9% 0 1
Flushing 10 1.8% 0 0
Underdose 10 1.8% 0 0
Abortion spontaneous 8 1.4% 0 0

Who Reports MIRIKIZUMAB-MRKZ Side Effects? Age & Gender Data

Gender: 50.2% female, 49.8% male. Average age: 48.9 years. Most reports from: US. View detailed demographics →

Is MIRIKIZUMAB-MRKZ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 1
2019 1 0 0
2020 1 0 0
2022 1 0 1
2023 23 1 15
2024 152 4 43
2025 74 2 15

View full timeline →

What Is MIRIKIZUMAB-MRKZ Used For?

IndicationReports
Colitis ulcerative 383
Product used for unknown indication 157
Crohn's disease 23
Colitis 5

MIRIKIZUMAB-MRKZ vs Alternatives: Which Is Safer?

MIRIKIZUMAB-MRKZ vs MIRTAZAPINE MIRIKIZUMAB-MRKZ vs MIRVETUXIMAB SORAVTANSINE-GYNX MIRIKIZUMAB-MRKZ vs MISOPROSTOL MIRIKIZUMAB-MRKZ vs MITAPIVAT MIRIKIZUMAB-MRKZ vs MITOMYCIN MIRIKIZUMAB-MRKZ vs MITOTANE MIRIKIZUMAB-MRKZ vs MITOXANTRONE MIRIKIZUMAB-MRKZ vs MITRAGYNINE\HERBALS MIRIKIZUMAB-MRKZ vs MIZORIBINE MIRIKIZUMAB-MRKZ vs MOBOCERTINIB

Official FDA Label for MIRIKIZUMAB-MRKZ

Official prescribing information from the FDA-approved drug label.